Who to blame for the delay in producing the swine flu vaccine?
Complex technology, large-scale programs run on tight deadlines, making products with almost no margin for error. Result: big potential for delays. As usual, coach-potatoes across the United States complain, and the blame game has already started. It’s America’s favorite pastime (much more fun than fixing our problems).
Other posts about the swine flue epidemic:
(1) What about all the hype, the extreme warnings, about swine flu?, 3 September 2009
(2) Update: about the swine flu epidemic, 9 October 2009
(3) Is the Swine Flu pandemic being used to an excuse to expand government powers (UK edition)?, 14 October 2009
(5) More about the swine flu pandemic: about Cassandras, 26 November 2009
Here are a few examples of this madness, most by people who think vaccines are as easily made as Dixie Cups.
- “Delay Undercuts H1N1 Vaccine Campaign“, Wall Street Journal, 19 October 2009 — About vaccine program delays caused by articles like this one, fanning baseless fears about vaccine safety.
- “The government has failed dramatically in its effort to make the swine flu vaccine widely available”, Paul, Powerline, 26 October 2009 — Paul show little knowledge about vaccines, but knows it’s the government’s fault.
- “The Swine Flu Vaccine Screw-up“, Barbara Ehrenreich, TomDispatch, 3 November 2009 — It’s Big Pharm’a fault!
- And then there are all the outright alarmist articles about thimerosal.
There have been a some in the news media working to sort out the various factors. Such as these two article in the Wall Street Journal. First, this one on 26 October 2009:
Manufacturing problems such as low yields from an initial H1N1 “seed” virus have hobbled plans for an initial delivery of a large number of doses. The seed virus didn’t grow well, which sometimes happens with flu viruses. Novartis AG, which has a contract to supply about 90 million doses to the U.S., said a U.S. request for a greater amount of its vaccine order in single-dose syringes also slowed the process.
Initially in late spring, government officials discussed ordering mostly multidose vials from Novartis, Andrin Oswald, head of the company’s vaccine business, said in an interview. Its primary concern at that point was to get a lot of vaccine quickly, he said. But in September, as more consumers started expressing concerns about thimerosal, a mercury-containing preservative used in multidose vials, the government requested more single-dose syringes, which contain only trace amounts of thimerosal. Officials wanted half of the October deliveries to be packaged in prefilled syringes, he said.
But the Department of Health and Human Services said it hadn’t issued a new order or modified its order to Novartis. “Over the past month HHS has been discussing with the manufacturer ways to make more vaccine available to the U.S. public sooner,” Bruce Gellin, director of the National Vaccine Program Office, said in an email. “These discussions have focused on reducing the number of pre-filled syringes supplied to HHS by Novartis. HHS has never issued or discussed a new delivery order or a modification to an existing delivery order that would increase the number of pre-filled syringes and delay supplies to the U.S. public.”
GlaxoSmithKline PLC, which has a contract to deliver 7.6 million doses, or about 3% of the total U.S. order, hasn’t received regulatory approval yet from the Food and Drug Administration for its vaccine. Glaxo filed its H1N1 vaccine application Sept. 4. The other four manufacturers received licenses for their vaccines in mid-September. Glaxo and the FDA are in discussions about the matter, and a Glaxo spokeswoman said Sunday that the FDA has given Glaxo no reason to believe that it has safety concerns about the vaccine, which is made in the same way as the company’s seasonal flu shots. The FDA declined to comment.
That’s the first level of complexity. To see deeper read “Why You Can’t Get the Swine Flu Vaccine“, Scott Gottlieb (a practicing physician, deputy commissioner of the FDA from 2005-2007), Wall Street Journal, 28 October 2009 — Excerpt (bold emphasis added):
The first fateful policy decision, made last spring, was to forgo vaccine additives — called adjuvants—that activate the immune system and make shots more potent. Adjuvants allow a smaller supply of vaccine stock to be stretched across more doses. These adjuvants are included in H1N1 vaccines world-wide, but not in the U.S.
Why do adjuvants matter? An adjuvanted H1N1 vaccine being used in Europe contains 3.75 micrograms of vaccine stock. The same vaccine in the U.S., without the adjuvant, requires 15 micrograms of vaccine for equal potency. If we used adjuvants, we could have had four times the number of shots with the same raw material.
The second cautious decision was to require that the H1N1 vaccine be a single shot. The government demanded single-dose syringes because they contain smaller amounts of thimerosal than multi-dose vials. This mercury-containing vaccine preservative continues to stir concern it can trigger childhood autism, even though this has been firmly disproven.
The third policy decision was to stick for too long with a proven, but slow process for making flu shots that uses chicken eggs to grow the raw vaccine material. Shots can be made much faster using mammalian cells to grow vaccine, and this process is already being used in Europe. The cell-based vaccines are unlikely to be approved in the U.S. Our precaution when it comes to vaccines means we don’t easily embrace novel technologies, even if the Europeans would part with some of their limited supply.
For more information
For a good summary, I recommend “Blowing the Shot – What we can learn from the shortage of H1N1 vaccine“, Marc Siegel, Slate, 2 November 2009 — A sensible look at the problems making a new vaccine.
Here is a wonderful graphics from the Information is Beautiful website, showing the relative seriousness of swine flu compared to other illnesses — and the power of hand washing to prevent its spread.
- “Egg Beaters – Flu vaccine makers look beyond the chicken egg“, Scientific American, 23 February 2004
- “Vaccine Production Is Horribly Outdated. Here Are 3 Ways to Fix It“, Discover, 27 July 2009
Articles about the Swine Flu on the FM website:
- What about all the hype, the extreme warnings, about swine flu?, 3 September 2009
- Update: about the swine flu epidemic, 9 October 2009
- Is the Swine Flu pandemic being used to an excuse to expand government powers – UK edition?, 15 October 2009
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